drug facts

drug facts

SPL v3

SPL

SPL Set ID 3be41f57-862b-472c-97a7-91d0a0a3074b

Route

oral

Published

Effective Date 2024-11-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

dimethicone (180 mg)

Inactive Ingredients

fd&c yellow no. 6 gelatin glycerin fd&c red no. 40

Identifiers & Packaging

Pill Appearance

Imprint: 05A Shape: oval Color: orange Size: 12 mm Score: 1

Marketing Status

otc monograph drug completed Since 2020-07-30 Until 2026-05-30

Purpose

Antigas

Description

Simethicone 180 mg

Medication Information

Purpose

Antigas

Directions

adult: swallow with water 1 or 2 softgels as needed after meals and at bedtime
do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician

Other Information

store between 15-30ºC (59-86ºF)
protect from heat and moisture

Inactive Ingredients

FD&C red #40*,FD&C yellow # 6, gelatin, glycerin

Description

Simethicone 180 mg

Principal Display Panel

COMPARE TO GAS-X® ULTRA STRENGTH ACTIVE NGREDIENT*

ULTRA STRENGTH

Gas Relief

ANTI-GAS/SIMETHICONE, 180 mg

FAST RELIEF OF

Bloating
Pressure
Fullness & Gas

SOFTGELS

**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X® Ultra Strength.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

www.topcarebrand.com

Use

For the relief of

pressure and bloating commonly referred to as gas

Package Label

TOPCARE HEALTH Ultra Strength Gas Relief

Questions Or Comments?

Calltoll free 1-888-423-0139

If Pregnant Or Breast Feeding,

ask a health care professional before use.

Active Ingredient (in Each Softgel)

Simethicone 180 mg

Structured Label Content

Purpose

Antigas

Directions

adult: swallow with water 1 or 2 softgels as needed after meals and at bedtime
do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician

Other Information (Other information)

store between 15-30ºC (59-86ºF)
protect from heat and moisture

Inactive Ingredients (Inactive ingredients)

FD&C red #40*,FD&C yellow # 6, gelatin, glycerin

Principal Display Panel

COMPARE TO GAS-X® ULTRA STRENGTH ACTIVE NGREDIENT*

ULTRA STRENGTH

Gas Relief

ANTI-GAS/SIMETHICONE, 180 mg

FAST RELIEF OF

Bloating
Pressure
Fullness & Gas

SOFTGELS

**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X® Ultra Strength.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

www.topcarebrand.com

Use

For the relief of

pressure and bloating commonly referred to as gas

Package Label

TOPCARE HEALTH Ultra Strength Gas Relief

Questions Or Comments? (Questions or comments?)

Calltoll free 1-888-423-0139

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health care professional before use.

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Simethicone 180 mg

Advanced Ingredient Data

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "180", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "For the relief of pressure and bloating commonly referred to as gas", "Purpose": "Antigas", "Directions": "adult: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician", "Package Label": "TOPCARE HEALTH Ultra Strength Gas Relief", "Other information": "store between 15-30ºC (59-86ºF) protect from heat and moisture", "Inactive ingredients": "FD&C red #40*,FD&C yellow # 6, gelatin, glycerin", "Questions or comments?": "Calltoll free 1-888-423-0139", "Principal Display Panel": "COMPARE TO GAS-X® ULTRA STRENGTH ACTIVE NGREDIENT* ULTRA STRENGTH Gas Relief ANTI-GAS/SIMETHICONE, 180 mg FAST RELIEF OF Bloating Pressure Fullness & Gas SOFTGELS **This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X® Ultra Strength. TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 www.topcarebrand.com", "If pregnant or breast-feeding,": "ask a health care professional before use.", "Active ingredient (in each softgel)": "Simethicone 180 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:24.840282 · Updated: 2026-03-14T23:05:07.358425